Liraglutide Licensed for Diabetes
The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes.
Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005.
It should be used with caution in people with a history of pancreatitis, the FDA said. The most common side effects observed with liraglutide were headache, nausea, and diarrhea.
Novo Nordisk is required to conduct postmarketing cardiovascular and cancer safety studies. Also included in the approval is a Risk Evaluation and Mitigation Strategy (REMS) consisting of a medication guide and a communication plan.
Oral Morphine Solution Approved
A concentrated oral solution of morphine sulfate has been approved, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.
The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.
The solution is indicated for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients, defined as those who are taking the equivalent of 60 mg/day of morphine. It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.
The FDA's decision is part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.
Combo Approved for Breast Cancer
The FDA approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.
A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.
In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.
“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.
In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.
Drug to Aid Walking in MS Okayed
A sustained-release formulation of the potassium channel blocker dalfampridine has been approved as a treatment to improve walking in people with multiple sclerosis.
In a statement, the FDA announced that dalfampridine extended-release tablets had been approved for this indication, based on studies that found patients treated with the drug had faster walking speeds than did those treated with placebo. This is the first drug approved for this indication, according to the FDA.
Dalfampridine will be marketed as Ampyra by Acorda Therapeutics.
The recommended dose of dalfampridine is 10 mg twice a day. However, higher doses have been associated with seizures, and the drug should not be taken by patients with moderate to severe kidney disease, whose blood levels with dalfampridine approach the levels that have been associated with seizures, according to the FDA statement.
The drug has a long history of use in the United States despite never having been approved, according to background documents filed by the FDA. For more than 20 years, dalfampridine has been compounded in pharmacies and used off-label to improve walking in people with various neurologic conditions.
McNeil Recalls More OTC Drugs
McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.
In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.
The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at